Field of the Invention
The present invention relates to aqueous formulations comprising an adenovirus vector and at least one anionic polymer. The present invention further relates to methods for the preparation of a storage stable adenovirus aqueous formulation.
Background
Recombinant adenovirus vectors are becoming increasingly important for use in vaccine development and gene therapy applications. Adenoviruses for gene therapy traditionally have been formulated and stored at less than −60° C. to ensure good virus stability during storage. When formulated conventionally as liquid compositions, such vectors are insufficiently stable during prolonged storage and/or at ambient temperature. There are some limited reports of aqueous formulations of adenovirus with stability data.
U.S. Pat. No. 7,456,009 describes adenovirus formulations with improved stability when stored at 2° C.-8° C. The formulations comprise a buffer, sugar, salt, divalent cation, non-ionic surfactant, and a free-radical scavenger.
U.S. Pat. No. 7,880,097 describes adenovirus formulation with bulking agents, cryoprotectants, and lyoprotectants in both aqueous and lyophilized formulations, allowing storage at 4° C. for up to six months.
There remains a need for adenovirus vector formulations having at least a twelve-month shelf-life, and preferably at least a twenty-four months shelf-life, at 2° C.-8° C. and for at least three months at 25° C.